Reduction of Breast Enlargement Using the Da Vinci Xi Robot
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Visible Scare
研究概览
简要总结
Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove.
The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.
详细描述
Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women.
The current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary "halo" of scar retraction. The project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular.
The expected result is to achieve a reduction in breast enlargement with no visible scar, using Da Vinci Xi robot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over the age of 18
- •Category 1 or 2 according to the classification of Regnault
- •Breast size cup c or more
- •Areola "looking in front", ie a distance between point A (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm
- •Ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position)
- •Expected correction of ptosis by half with reduction of 1 to 3 cup sizes
- •Good quality thick skin
- •Affiliated patient or beneficiary of a social security scheme
- •Patient requesting breast reduction
- •Patient who signed free and informed consent
排除标准
- •Areola "look down"; point A more than 25 cm
- •Ptose greater than and equal to 8 cm
- •Thin skin
- •Patient on anti-coagulant
- •Patient participating in another clinical study
- •Protected patient: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
- •Pregnant, lactating woman
结局指标
主要结局
Number of Visible Scare
时间窗: 3 months
The main judgment criterion for the scar balance will be a photograph of the breasts at 3 months to describe the number of visible scars. Aspect and position.
次要结局
- Intensity of Back Pain(3 months)
- Efficacity of the reduction (weight)(day of surgery)
- Skin retraction(at 3 months)